Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability
21. juli 2026 oppdatert av: Yoojin Cho, Ohio State University Comprehensive Cancer Center
This randomized, double-blind, crossover human laboratory study compares the abuse liability of cigarettes containing menthol and non-menthol cigarette variants, using the participant's usual brand menthol cigarette as a within-subject reference.
Participants complete standardized laboratory smoking sessions, behavioral economic tasks, and a naturalistic observational period.
The study examines differences in nicotine delivery, smoking behavior, and subjective effects across cigarette types in laboratory and real-world contexts.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
Participants complete a three-phase protocol over approximately three weeks, comprising five in-person laboratory visits and two one-week daily-diary periods.
In Phase 1, participants attend a 3-hour baseline laboratory visit after a 12-hour abstinence from nicotine, tobacco, and smoked cannabis. They smoke one usual brand menthol cigarette (UBMC) in a standardized session (10 puffs over 5 minutes) while puff topography is recorded. Serial 3 mL blood samples are collected at -5, +5, +15, +30, and +60 minutes relative to smoking initiation. Subjective effects (e.g., product appeal, sensory perception, craving) are assessed before and after smoking, followed by the Cigarette Purchase Task (CPT). Participants then complete brief surveys three times daily for one week to capture product use and subjective effects in the natural environment.
In Phase 2, participants return for three additional laboratory visits, each separated by at least 48 hours, and smoke one of three blinded study products in a randomized order; study coordinators remain blinded. Each visit follows the Phase 1 procedures (standardized smoking session, topography, serial blood sampling, and subjective ratings). After smoking, participants complete the CPT and the Cross-Price Elasticity Task (CPET), in which the price of UBMC increases while the study product remains fixed, characterizing substitutability.
In Phase 3, participants identify their preferred study product and receive a one-week supply, with instructions to use it exclusively in place of their UBMC. They continue the three-times-daily survey schedule throughout the week. The phase concludes with a final 2-hour laboratory visit including a remaining-cigarette count and the Progressive Ratio Task (PRT), providing a measure of the relative reinforcing value of the preferred study product vs. UBMC.
Studietype
Intervensjonell
Registrering (Antatt)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: The Ohio State University Comprehensive Cancer Center
- Telefonnummer: 800-293-5066
- E-post: OSUCCCClinicaltrials@osumc.edu
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Ta kontakt med:
- Yoo Jin Cho, PhD, MPH
- Telefonnummer: 614-366-7048
- E-post: Yoojin.cho@osumc.edu
-
Hovedetterforsker:
- Yoo Jin Cho, PhD, MPH
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Aged 21 years or older
- Currently smoke cigarettes daily (≥ 5 cigarettes/day) for at least the past 6 months, and their usual brand is menthol cigarettes
- Willing to provide informed consent
- Willing to abstain from all nicotine, tobacco, and smoked cannabis products for approximately 12 hours prior to each study visit
- Own and regularly use a functional smartphone compatible with study procedures (e.g., completing daily assessments)
- Willing to complete two weeks of daily assessments involving use of their usual brand menthol cigarettes and the study product
- Able to read, speak, and understand English
Exclusion Criteria:
- Current diagnosis of any significant lung diseases (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis)
- History of a cardiac event or episode of cardiac distress (e.g., heart attack, hospitalization for chest pain) within the past 3 months
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Self-reported use of any non-cigarette nicotine or tobacco product (e.g., e-cigarettes, cigars, oral nicotine products) or cannabis on more than 10 days in the past 30 days
- Self-reported current participation in a smoking cessation program or intention to quit smoking in the next 3 months
- Self-reported difficulty with blood draws
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Study Cigarette A
Participants smoke one Study Cigarette A during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
|
|
Eksperimentell: Study Cigarette B
Participants smoke one Study Cigarette B during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
|
|
Eksperimentell: Study Cigarette C
Participants smoke one Study Cigarette C during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Plasma nicotine (Cmax)
Tidsramme: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.
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During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Appeal ratings (Labeled Hedonic Scale)
Tidsramme: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
The Labeled Hedonic Scale (LHS) is a self-reported measure of appeal.
Scores range from -100 (most disliked imaginable) to 100 (most liked imaginable) with higher scores indicating a greater degree of liking.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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Puff topography
Tidsramme: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Puffing topography will be summarized with total puff count, average puff duration, average inter-puff interval, average puff volume, total puff volume, average flow rate, and peak flow rate.
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During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Sensory effects (general Labeled Magnitude Scale)
Tidsramme: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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The general Labeled Magnitude Scale (gLMS) is a 5-item self-report measure of sensory effects.
Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Nicotine craving and withdrawal (Questionnaire of smoking urges)
Tidsramme: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Craving relief will be assessed using Questionnaire of Smoking Urges (QSU).
The QSU is made up of 10 statements about the respondent's feelings and thoughts about desire to smoke cigarettes as they are completing the questionnaire.
The scoring comprises of two factors, each the sum of 5 items.
The scores for each factor range from 5-35, and the total score (the sum of all 10 items) ranges from 10-70.
For each factor and for the total score, higher scores indicate more severe urges.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
Tidsramme: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
Withdrawal will be assessed using Minnesota Nicotine Withdrawal Scale (MNWS).
Items are rated on a 5-point scale from 0 (none) to 4 (severe).
MNWS is the sum of 8 items with scores ranging from 0 to 32 with higher scores indicating more severe overall withdrawal.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
Tidsramme: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
MNWS-Craving will be calculated which uses a single item from the MNWS that is scored from 0-4 with higher scores indicating greater craving.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Breakpoint
Tidsramme: Post Phase 2 smoking sessions, assessed up to 3 weeks
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Breakpoint will be defined as the first price at which cigarette consumption is zero during the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Demand intensity (Q0)
Tidsramme: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
Demand intensity will be defined as cigarette consumption at the lowest cigarette price of $0 during the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Maximum financial expenditure on cigarettes (Omax)
Tidsramme: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the maximum financial expenditure.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Price at which expenditure is maximized (Pmax)
Tidsramme: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the price at which expenditure is maximized.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Demand elasticity (alpha)
Tidsramme: Post Phase 2 smoking sessions, assessed up to 3 weeks
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Sensitivity of cigarette consumption to increase in price assessed using the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Cross-over price
Tidsramme: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
The price at which two options valued approximately equally will be calculated from the Cross Price Elasticity Task (CPET).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
|
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Progressive ratio task
Tidsramme: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
The proportion of puffs allocated to the study products versus usual brand menthol cigarettes (UBMC) will be measured with the Progressive Ratio Task (PRT).
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
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Preferred product selection
Tidsramme: Post Phase 2 smoking sessions, assessed up to 3 weeks
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Count of participants selecting each of the 3 study products after completion of the 3 Phase 2 smoking sessions.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
|
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Product substitution
Tidsramme: 1 week Phase 3 substitution period
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Substitution assessed via use behavior during Phase 3 will be operationalized as the ratio of study product to UBMC used, with a ratio > 0 indicating any substitution and a ratio > 1 indicating substitution of study product for the UBMC at least 50% of the time.
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1 week Phase 3 substitution period
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yoo Jin Cho, PhD, MPH, Ohio State University Comprehensive Cancer Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
27. juli 2026
Primær fullføring (Antatt)
30. september 2029
Studiet fullført (Antatt)
30. september 2029
Datoer for studieregistrering
Først innsendt
27. april 2026
Først innsendt som oppfylte QC-kriteriene
27. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OSU-25014
- K01DA061444 (U.S. NIH-stipend/kontrakt)
- NCI-2026-01493 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data will be archived through the National Addiction & HIV Data Archive Program (NAHDAP) at the Inter-university Consortium for Political and Social Research (ICPSR).
Access requires a Restricted Data Use Agreement.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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